MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for TILT IN SPACE NA:SOLARA3G SOLARA3G manufactured by .
[175083775]
This record is being filed in an abundance of caution. At the time of this filing, no malfunctions or deficiencies have been alleged. Invacare was made aware of this event that occurred in the (b)(6) with a rea azalea wheelchair. This record was created due to the u s. Manufactured solara 3g being similar in design and would likely to have the same adverse outcome as this event. Invacare does not know the age of the device, so the manufacturing facility is unknown. The solara 3g, was at one time manufactured at invacare (b)(4), and then manufacturing was moved to invamex, the rea azalea has not been returned to invacare (b)(4) for an evaluation. If more information becomes available a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[175083776]
Invacare was notified a patient has died while in the rea azalea wheelchair, in what we believe is a cigarette related fire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2020-00005 |
| MDR Report Key | 9592326 |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-16 |
| Report Date | 2020-01-15 |
| Date Reported to FDA | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-01-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TILT IN SPACE |
| Generic Name | WHEELCHAIR, MECHANICAL |
| Product Code | IOR |
| Date Received | 2020-01-15 |
| Model Number | NA:SOLARA3G |
| Catalog Number | SOLARA3G |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-01-15 |